Health Highlights: Feb. 28, 2012

Hundreds of thousands of people who received artificial metal-on-metal hips made by Johnson & Johnson, among others, may face serious health threats, including long-term disability, British health experts report.

The BMJ and BBC researchers said more people are at risk from the metal artificial hips than are affected by faulty breast implants made in France, the subject of another recent European medical device scare.

Their investigation found that toxic cobalt and chromium ions in the artificial hips can penetrate tissue and enter the bloodstream, spreading to major organs and killing bone and muscle, according to Bloomberg News.

Dr. Carl Heneghan, director of the University of Oxford's Centre for Evidence-Based Medicine, said in a BMJ statement that a uniform, international system to assess and monitor implantable medical devices would help safeguard patients around the globe.

"Creating an independent system for post-marketing analysis for implantable medical devices that is robust and increasing international coordination around device alerts and withdrawals should go some way to sorting out the current mess," Heneghan said, according to Bloomberg.

In December, reports that breast implants made by Poly Implants Protheses SA were leaking industrial silicone led French and German officials to recommend that thousands of women have the implants removed.

The hips the researchers studied included those made by New Jersey-based J&J; Zimmer Holdings of Indiana, and a London company, Smith & Nephew Plc (SN).

Because medical devices don't need the same type of clinical testing in Europe required of new drugs, the hips were implanted in patients without adequate safety studies, the researchers said. Potentially risky design changes made over the past 10 years weren't flagged by regulators and brought to the attention of doctors and patients.

Heneghan said procedures for medical device approval in Europe are less stringent than in the United States. In the United States, tests of medical devices are government-run under the Food and Drug Administration, and manufacturers must provide proof of safety and effectiveness. In the EU, however, manufacturers need only prove the devices are safe, and they can choose from about 70 private firms, called "notified bodies," to test their products, the Bloomberg report stated. Approval from one firms enables the manufacturer to market the device throughout the 27 EU nations.

Study co-author Nick Freemantle, professor of clinical epidemiology and biostatistics at University College London, said the current approval standards are dated. "The methods of device regulation seem to be more from the 1950s than the 21st century," he wrote in the study, Bloomberg reported.

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Condom-Use Errors Common, Study Finds

An analysis of data from 50 studies across 14 countries finds that errors in using condoms are common and could contribute to unwanted pregnancies or sexually transmitted infections.

Stephanie Sanders and colleagues at The Kinsey Institute for Research in Sex, Gender, and Reproduction at Indiana University looked at 16 years of data on the issue, mainly from the United States and Britain.

They found that:

Between 17 and 51 percent of people put condoms on partway during intercourse (dangerous because fluids can be exchanged prior to ejaculation). Between 13 percent and 45 percent of respondents said they took a condom off before intercourse had finished.

Between one-quarter and one-half of respondents said they failed to leave enough room at the tip of the condom for semen to collect.

75 percent of men and 82 percent of women failed to check condoms for damage prior to use.

Condom breakages occurred for between about 1 percent and 41 percent of respondents, depending on the study, and between about 13 and 19 percent said they had experienced condom slippage.

Between 4 percent and just over 30 percent of participants said they had put a condom on inside-out, then flipped it the other way around, potentially upping the risk for transmission of bodily fluids.

Between 2 percent and 11 percent of people opened condom packets with a sharp object or somehow exposed the condom to rips/tears. Between 1 percent and 3 percent of respondents said they had re-used a condom during a sexual encounter.

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